Optical Coherence Tomography of Nerve Fiber Layer and Ganglion Cell Complex After Cataract Extraction

Cataract Clinical Trial

Official title:

Comparison Between OCT Nerve Fiber Layer and Ganglion Cell Complex Parameters Following Cataract Extraction in Patients With or Without Primary Open Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889652
• Other study ID #: N-68-2018
• Status: Completed
• Start date: October 20, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: March 2019
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Optical coherence tomography (OCT) for retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) is done before and after cataract extraction in patients with or without primary open angle glaucoma (POAG)

Description:

The investigator's study includes two groups of patients, each consists of 25 eyes, group 1 (cataract group)includes patients who are planned for cataract extraction without any other preexisting retinal or optic nerve pathology that may affect the RNFL thickness, while group 2 (combined cataract and glaucoma group) includes patients who are diagnosed with POAG controlled on medical treatment with cataract and planned for cataract extraction only.

The OCT scans with complete ophthalmological examination are done before surgery and 6 weeks after uneventful cataract extraction (phacoemulsification with intraocular lens implantation)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 20, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• patients with cataract without any other concomitant retinal, optic nerve head pathology other than POAG are included in the study and divided onto two groups

Exclusion Criteria:

• Patients having any retinal or optic nerve pathology that might have affected nerve fiber layer thickness other than POAG eg: high myopia

• POAG patients who are planned for combined surgery

• Refractive errors greater than spherical equivalent of 6 diopters (myopia or hypermetropia)

• Dense cataract hindering OCT imaging

• History of previous ocular surgery or trauma

Related Conditions & MeSH terms

• Cataract
• Ganglion Cysts
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Diagnostic Test:
• Oct scans
Oct scans to assess thickness of RNFL and GCC before and after cataract extraction surgery in both groups

Locations

Country	Name	City	State
Egypt	Kasr Al-Ainy teaching hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraocular pressure (IOP) change and central foveal thickness (CFT) change	Assessment of the IOP and CFT change after cataract extraction	Six weeks after cataract surgery
Primary	RNFL and GCC thickness	Assessment of RNFL and GCC thickness change after cataract extraction	Oct scans before and 6 weeks after surgery
Secondary	Final best corrected visual acuity (BCVA)	Assessment of the final BCVA recorded according to the Snellen chart and converted to logMAR for statistical analysis	Six weeks after cataract surgery